Provide comprehensive support to Operations in all areas of production quality assurance.
• Provide Quality support for the manufacture of legacy products. Support includes process improvements, product non-compliance analysis, and process changes.
Responsibilities include:
• Assure assigned product lines and manufacturing processes are to the highest quality and are compliant to internal and external regulations such as QSR 820 and ISO13485.
• Partner with manufacturing engineer to provide day-to-day support of assigned product lines. Actively participate in team meetings and daily status meetings.
Provide support to the actual manufacturing line within the Clean Environmental
Area.
• Lead or actively participate in addressing issues that affect the quality of the product and/or the manufacturing lines, such as analysis and disposition of non-conforming products. Identify opportunities for improvement of the product and/or the process.
• Actively participate in audits / assessments of the manufacturing operations, and recommends corrective / preventive actions and process improvements.
• Applies and understands statistical methodologies, as appropriate, for conformity assessment and investigative activities.
• Works with cross-functional groups to implement new products.
• Works with minimal supervision.
Bachelor’s degree in Engineering discipline.
• Minimum 2 to 4 years quality assurance experience in a GMP environment or highly regulated industry with BS Degree. Minimum 0 to 2 years experience with
Masters Degree.
• Experience working in a team environment.
• Effective verbal and written communication, analytical, influencing and interpersonal skills.
• Must be able to communicate at all levels and across company lines.
• PC skills, word processing, spreadsheets, project management, etc. Basic
Statistical Knowledge and Application
• Adhere to the Medtronic Core Behaviors of Customer Focus, Candor, Trust and
Respect, Courage, Accountability, and Passion to Win
Desired/Preferred Qualifications
• ASQC certification.
• Masters degree in engineering discipline.
• 4 or more years of quality assurance experience in a GMP, disposable medical device environment.
• Molding and software experience.
To know more about this opportunity, please contact:
Sagar Rathore
Sagar.rathore(at)collabera.com
630-485-2166
Job details are sourced from the employer's original posting.
Open job postingAbout the company
We provide cost-effective, high quality IT resources to meet talent needs through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera has been a leader in IT staffing for over 24 years and is one of the largest diversity IT staffing firms in the industry. We are known for our high-touch, customer-centric approach, offering our clients unmatched quality, responsiveness and flexibility. We are appreciated by our clients for our streamlined execution, highly efficient service and exceptional talent management that go above and beyond traditional staffing services. Collabera has been named the Best Staffing Firm to Work For in the large firm category by Staffing Industry Analysts, the global advisor on contingent work, for four consecutive years.